Table 2.
Study design and patient cohort/ward in published studies using the SeptiFast test
| Title of publication | Study design | Patient cohort/ward | Reference |
|---|---|---|---|
| New diagnostic tools for neonatal sepsis: The role of a real-time polymerase chain reaction for the early detection and identification of bacterial and fungal species in blood samples | Review | Oncohematological malignancies, and other febrile states |
[142] |
| Molecular diagnosis of sepsis in neutropenic patients with hematological malignancies | Prospective | Hematological malignancies | [106] |
| Multiplex polymerase chain reaction detection enhancement of bacteremia and fungemia | Retrospective | IR and ICU Sepsis | [95, 100] |
| A multiplex real-time PCR assay for rapid detection and differentiation of 25 bacterial and fungal pathogens from whole blood samples | Non clinical performance and observational data | N/A | [95] |
| Automatic detection of bacterial and fungal infections in blood | Retrospective | Sepsis patients | [171] |
| LightCycler SeptiFast assay as a tool for the rapid diagnosis of sepsis in patients during antimicrobial therapy | Prospective | ICU and febrile BMT recipients | [143] |
| Molecular diagnosis of polymicrobial sepsis | Letter to Editor | Sepsis patients | [110] |
| Blood culture systems: rapid detection – how and why? | Review | N/A | [172] |
| Laboratory diagnosis of late-onset sepsis in newborns by multiplex real-time PCR | Correspondence | Neonates | [90] |
| Invasive aspergillosis in two liver transplant recipients: diagnosis by SeptiFast | Case report | Liver Transplant recipients | [111] |
| Diagnosis of bloodstream infections in immunocompromised patients by real-time PCR | Interventional study | Cancer | [16] |
| Microbiological sepsis screening in surgical ICU patients with the “Lightcycler” Septifast Test – A pilot study | Pilot study | Surgical ICU | [173] |
| Evaluation of the LightCycler® SeptiFast test in the rapid etiologic diagnosis of infectious endocarditis | Prospective | Definite endocarditis | [122] |
| Multiplex real time PCR and blood culture for ID of blood stream pathogens in patients with suspected sepsis | Observational | ICU Sepsis | [97] |
| Utility of a commercially available multiplex real-time PCR assay to detect bacterial and fungal pathogens in febrile neutropenia | Retrospective | Febrile neutropenia after chemotherapy | [105] |
| Clinical impact of a commercially available multiplex PCR system for rapid detection of pathogens in patients with presumed sepsis | Retrospective | Presumed sepsis | [102] |
| Improved detection of blood stream pathogens by real-time PCR in severe sepsis | Observational | ICU Sepsis | [145] |
| A multicentre trial to compare blood culture with polymerase chain reaction in severe human sepsis | Observational | ICU Sepsis | [103] |
| Potential clinical utility of polymerase chain reaction in microbiological testing for sepsis | Observational | ICU Sepsis | [98] |
| Use of the LightCycler SeptiFast Test for rapid etiologic diagnosis of nosocomial infection in gynecological sepsis | Case reports | Gynecological sepsis | [174] |
| Evaluation of pathogen detection from clinical samples by real-time polymerase chain reaction using a sepsis pathogen DNA detection kit | Prospective | SIRS | [146] |
| Preliminary clinical study using a multiplex real-time PCR test for detection of bacterial 4 and fungal DNA directly in blood | Prospective; observational | ICU Sepsis | [112] |
| Molecular identification of bloodstream pathogens in patients presenting to the emergency department with suspected sepsis | Retrospective | Suspected sepsis in the ER | [175] |
| Evaluación de una PCR multiplex en tiempo real para la detección de patógenos en el tejidovalvular de pacientes con endocarditis | Prospective | Valve tissues | [126] |
| Multiplex PCR allows rapid and accurate diagnosis of bloodstream infections in newborns and children with suspected sepsis | Retrospective | Neonates and children | [119] |
| Therapeutic impact and diagnostic performance of multiplex PCR in patients with malignancies and suspected sepsis | Prospective | Cancer and sepsis | [176] |
| Cost and mortality prediction using polymerase chain reaction pathogen detection in sepsis: evidence from three observational trials | Retrospective analysis/ mathematical prediction | N/A | [155] |
| Multiplex blood PCR in combination with blood cultures for improvement of the microbiological documentation of infection in febrile neutropenia | Prospective, observational | Hematological malignancies | [107] |
| Automated extraction improves multiplex molecular detection of infection in septic patients | Analytical method comparison | N/A | [96] |
| Is detection of bacterial DNA in ascitic fluid of clinical relevance? | Prospective | Cirrhosis and ascites samples | [125] |
| Rapid qualitative urinary tract infection pathogen identification by SeptiFast real-time PCR | Retrospective | UTI | [124] |
| Molecular biological sepsis diagnostic using multiplex PCR in surgical intensive care as suitable alternative to conventional microbial culture – a representative overview | Retrospective | Surgical ICU | [177] |
| Diagnostic accuracy and potential clinical value of the LightCycler SeptiFast assay in the management of bloodstream infections occurring in neutropenic and critically ill patients | Retrospective | Neutropenia, ICU | [178] |
| Establishment of a semi-automated pathogen DNA isolation from whole blood and comparison with commercially available kits | Analytical | N/A | [131] |
| The clinical diagnostic accuracy of rapid detection of healthcare-associated bloodstream infection in intensive care using multipathogen real-time PCR technology | Prospective | HAI-associated bloodstream infection | [179] |
| Multiplex polymerase chain reaction pathogen detection in patients with suspected septicemia after trauma, emergency, and burn surgery | Prospective | ICU, ED, burn | [116, 180] |
| [The first experience of application of PCR techniques in real-time mode to diagnose bacteriemia during postoperational period in cardiosurgery patients] | Retrospective | Post-surgery | [181] |
| Performance of the LightCycler SeptiFast test Mgrade in detecting microbial pathogens in purulent fluids | Retrospective | Pyogenic infections | [182] |
| Usefulness of real-time PCR for the diagnosis of sepsis in ICU-acquired infections | Review | ICU | [101] |
| Molecular diagnosis of Aspergillus fumigatus endocarditis | Case report | CLL | [183] |
| Evaluation of a commercial multiplex PCR test (SeptiFast) in the etiological diagnosis of community-onset bloodstream infections | Retrospective | Community-onset sepsis | [5] |
| [Matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF) mass spectrometry vs conventional methods in the identification of Candida non-albicans] | Analytical | Candida isolates | [184] |
| Multiplex PCR pathogen detection in two severely burned patients with suspected septicemia | Case reports | Burn | [116] |
| Comparison of conventional culture with SeptiFast real-time PCR for microbial pathogen detection in clinical specimens other than blood | Retrospective | Antimicrobial therapy | [185] |
| Procalcitonin predicts real-time PCR results in blood samples from patients with suspected sepsis | Retrospective | Suspected sepsis | [186] |
| Results and relevance of molecular detection of pathogens by SeptiFast – A retrospective analysis in 75 critically ill children | Retrospective | Pediatric ICU | [113]. |
| Accuracy of LightCycler® SeptiFast for the detection and identification of pathogens in the blood of patients with suspected sepsis: a systematic review protocol | Review | Suspected sepsis | [187] |
| LightCycler SeptiFast technology in patients with solid malignancies: clinical utility for rapid etiologic diagnosis of sepsis | Retrospective | Solid malignancies, ICU | [188] |
| PCR-based rapid sepsis diagnosis effectively guides clinical treatment in patients with new onset of SIRS | Retrospective | Abdominal sepsis | [144] |
| Rapid detection of bloodstream pathogens by real-time PCR in patients with sepsis | Retrospective | Sepsis | [92] |
| Diagnostic performance of multiple real-time polymerase chain reaction assay in patients with suspected sepsis hospitalized in an internal medicine ward | Prospective | Suspected sepsis | [189] |
| Diagnosis, management and outcome of Candida endocarditis | Prospective | Candida endocarditis | [123] |
| Bacterial lung sepsis in patients with febrile neutropenia | Review | Febrile neutropenia | [190, 191] |
| Molecular approaches in the diagnosis of sepsis in neutropenic patients with hematological malignances | Prospective | Neutropenia | [108] |
| Rapid detection of bloodstream pathogens by real-time PCR in patients with sepsis | Retrospective | Sepsis | [92] |
| Diagnostic performance of multiple real-time polymerase chain reaction assay in patients with suspected sepsis hospitalized in an internal medicine ward | Prospective | Suspected sepsis | [189] |
| Diagnosis, management and outcome of Candida endocarditis | Prospective | Candida endocarditis | [123] |
| Bacterial lung sepsis in patients with febrile neutropenia | Review | Febrile neutropenia | [190, 191] |
| Molecular approaches in the diagnosis of sepsis in neutropenic patients with hematological malignances | Prospective | Neutropenia | [108] |
| Diagnosis of infective endocarditis: comparison of the LightCycler SeptiFast real-time PCR with blood culture | Retrospective | Endocarditis | [191] |
| Multiplex PCR for rapid and improved diagnosis of bloodstream infections in liver transplant recipients | Retrospective | Liver transplant | [117] |
| Invasive candidiasis: a review of nonculture-based laboratory diagnostic methods | Review | Candidiasis | [192] |
| Diagnostic utility of LightCycler SeptiFast and procalcitonin assays in the diagnosis of bloodstream infection in immunocompromised patients | Retrospective | Immunosuppression | [193] |
| Cost analysis of real-time polymerase chain reaction microbiological diagnosis in patients with septic shock | Cost-minimization study | Septic shock | [17] |
| Evaluation of the LightCycler SeptiFast test in newborns and infants with clinical suspicion of sepsis | Retrospective | Neonatal ICU | [120] |
| Microbial diagnosis in patients with presumed severe infection in the emergency department | Retrospective | Emergency room | [104] |
| Routine use of a real-time polymerase chain reaction method for detection of bloodstream infections in neutropenic patients | Retrospective | Neutropenics | [194] |
| Comparison of two molecular assays with conventional blood culture for diagnosis of sepsis | Retrospective | Critical illness | [127] |
| Molecular detection of late-onset neonatal sepsis in
premature infants using small blood volumes: Proof-of-concept |
Experimental | Neonates | [121] |
| Comparison of three different commercial PCR assays for the detection of pathogens in critically ill sepsis patients | Prospective, observational | Sepsis | [128] |
| The value of combining blood culture and SeptiFast data for predicting complicated bloodstream infections caused by gram-positive bacteria or candida species | Prospective | Sepsis | [195] |
| Use of a multiplex polymerase chain reaction system for enhanced bloodstream pathogen detection in thoracic transplantation | Observational | Thoracic allograft recipients (heart and lung) | [118] |
| Multiplex PCR system for rapid detection of pathogens in patients with presumed sepsis – a systemic review and meta-analysis | Systemic review/meta-analysis | Patients with presumed sepsis | [99] |
| Use of SeptiFast for the detection of bacterial meningitis | Retrospective | Suspected meningitis (cerebrospinal fluid ) | Infection, in press |